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      Improving access to affordable quality-assured inhaled medicines in low- and middle-income countries

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      1 , 2 , 3 , 4 , 1 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 1 , 12 , 13 , 14 , 15 , 16 , 1 , 17 , 18 , 19 , 5 , 20 , 13 , 5 , 5 , 21 , 22 , 23 , 24 , 25 , 26 , 13 , 27 , 28 , 29 , 20 , 26 , 24 , 30 , 31 , 32 , 13 , 33 , 13 , 34 ,
      The International Journal of Tuberculosis and Lung Disease
      International Union Against Tuberculosis and Lung Disease
      asthma, COPD, non-communicable disease, chronic respiratory disease, inhalers, essential medicines

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          SUMMARY

          BACKGROUND :

          Access to affordable inhaled medicines for chronic respiratory diseases (CRDs) is severely limited in low- and middle-income countries (LMICs), causing avoidable morbidity and mortality. The International Union Against Tuberculosis and Lung Disease convened a stakeholder meeting on this topic in February 2022.

          METHODS :

          Focused group discussions were informed by literature and presentations summarising experiences of obtaining inhaled medicines in LMICs. The virtual meeting was moderated using a topic guide around barriers and solutions to improve access. The thematic framework approach was used for analysis.

          RESULTS :

          A total of 58 key stakeholders, including patients, healthcare practitioners, members of national and international organisations, industry and WHO representatives attended the meeting. There were 20 pre-meeting material submissions. The main barriers identified were 1) low awareness of CRDs; 2) limited data on CRD burden and treatments in LMICs; 3) ineffective procurement and distribution networks; and 4) poor communication of the needs of people with CRDs. Solutions discussed were 1) generation of data to inform policy and practice; 2) capacity building; 3) improved procurement mechanisms; 4) strengthened advocacy practices; and 5) a World Health Assembly Resolution.

          CONCLUSION :

          There are opportunities to achieve improved access to affordable, quality-assured inhaled medicines in LMICs through coordinated, multi-stakeholder, collaborative efforts.

          Translated abstract

          CONTEXTE :

          Dans les pays à faible revenu et à revenu intermédiaire (LMIC), l’accès aux médicaments par inhalation abordables pour les maladies respiratoires chroniques (CRD) est extrêmement limité et entraîne une morbidité et une mortalité qui pourraient être évitées. L’Union internationale contre la tuberculose et les maladies respiratoires a réuni les parties prenantes concernées lors d’une réunion à ce sujet en février 2022.

          MÉTHODES :

          Les discussions ciblées de groupe étaient étayées par les données de la littérature et des présentations synthétisant les différentes expériences en matière d’accès aux médicaments par inhalation dans les LMIC. Le déroulement de la réunion en ligne respectait les thèmes définis dans un guide dédié portant sur les obstacles et solutions visant à améliorer cet accès. Cette approche thématique a été utilisée pour l’analyse.

          RÉSULTATS :

          Au total, 58 parties prenantes clés (dont patients, personnel soignant, membres d’organisations nationales et internationales, représentants de l’industrie et de l’OMS) ont pris part à cette réunion. Avant la réunion, 20 éléments de documentation ont été soumis. Les principaux obstacles identifiés étaient : 1) une mauvaise connaissance des CRD, 2) des données limitées sur le poids sanitaire des CRD et les traitements dans les LMIC, 3) l’inefficacité des réseaux d’approvisionnement et de distribution et 4) une mauvaise communication quant aux besoins des patients atteints de CRD. Les solutions évoquées étaient : 1) génération de données pour orienter les politiques et la pratique, 2) renforcement des capacités, 3) amélioration des mécanismes d’approvisionnement, 4) renforcement des pratiques de plaidoyer et 5) adoption d’une résolution par l’Assemblée mondiale de la santé.

          CONCLUSION :

          Il est possible d’améliorer l’accès à des traitements par inhalation abordables de qualité dans les LMIC, au travers d’efforts collaboratifs et coordonnés impliquant toutes les parties prenantes.

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          Most cited references30

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          The availability and affordability of selected essential medicines for chronic diseases in six low- and middle-income countries.

          To assess the availability and affordability of medicines used to treat cardiovascular disease, diabetes, chronic respiratory disease and glaucoma and to provide palliative cancer care in six low- and middle-income countries. A survey of the availability and price of 32 medicines was conducted in a representative sample of public and private medicine outlets in four geographically defined areas in Bangladesh, Brazil, Malawi, Nepal, Pakistan and Sri Lanka. We analysed the percentage of these medicines available, the median price versus the international reference price (expressed as the median price ratio) and affordability in terms of the number of days wages it would cost the lowest-paid government worker to purchase one month of treatment. In all countries
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            Improving lung health in low-income and middle-income countries: from challenges to solutions

            Low-income and middle-income countries (LMICs) bear a disproportionately high burden of the global morbidity and mortality caused by chronic respiratory diseases (CRDs), including asthma, chronic obstructive pulmonary disease, bronchiectasis, and post-tuberculosis lung disease. CRDs are strongly associated with poverty, infectious diseases, and other non-communicable diseases (NCDs), and contribute to complex multi-morbidity, with major consequences for the lives and livelihoods of those affected. The relevance of CRDs to health and socioeconomic wellbeing is expected to increase in the decades ahead, as life expectancies rise and the competing risks of early childhood mortality and infectious diseases plateau. As such, the World Health Organization has identified the prevention and control of NCDs as an urgent development issue and essential to the achievement of the Sustainable Development Goals by 2030. In this Review, we focus on CRDs in LMICs. We discuss the early life origins of CRDs; challenges in their prevention, diagnosis, and management in LMICs; and pathways to solutions to achieve true universal health coverage.
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              Is Open Access

              Partnering With Patients in the Development and Lifecycle of Medicines

              The purpose of medicines is to improve patients' lives. Stakeholders involved in the development and lifecycle management of medicines agree that more effective patient involvement is needed to ensure that patient needs and priorities are identified and met. Despite the increasing number and scope of patient involvement initiatives, there is no accepted master framework for systematic patient involvement in industry-led medicines research and development, regulatory review, or market access decisions. Patient engagement is very productive in some indications, but inconsistent and fragmentary on a broader level. This often results in inefficient drug development, increasing evidence requirements, lack of patient-centered outcomes that address unmet medical needs and facilitate adherence, and consequently, lack of required therapeutic options and high costs to society and involved parties. Improved patient involvement can drive the development of innovative medicines that deliver more relevant and impactful patient outcomes and make medicine development faster, more efficient, and more productive. It can lead to better prioritization of early research; improved resource allocation; improved trial protocol designs that better reflect patient needs; and, by addressing potential barriers to patient participation, enhanced recruitment and retention. It may also improve trial conduct and lead to more focused, economically viable clinical trials. At launch and beyond, systematic patient involvement can also improve the ongoing benefit-risk assessment, ensure that public funds prioritize medicines of value to patients, and further the development of the medicine. Progress toward a universal framework for patient involvement requires a joint, precompetitive, and international approach by all stakeholders, working in true partnership to consolidate outputs from existing initiatives, identify gaps, and develop a comprehensive framework. It is essential that all stakeholders participate to drive adoption and implementation of the framework and to ensure that patients and their needs are embedded at the heart of medicines development and lifecycle management.
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                Author and article information

                Journal
                Int J Tuberc Lung Dis
                Int J Tuberc Lung Dis
                jtld
                The International Journal of Tuberculosis and Lung Disease
                International Union Against Tuberculosis and Lung Disease
                1027-3719
                1815-7920
                November 2022
                1 November 2022
                : 26
                : 11
                : 1023-1032
                Affiliations
                [1 ]Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK
                [2 ]Stellenbosch University, Tygerberg, South Africa
                [3 ]Education Department, Liverpool School of Tropical Medicine, Liverpool, UK
                [4 ]Academic Unit of Primary Care, University of Sheffield, Sheffield, UK
                [5 ]IcFEM Dreamland Mission Hospital, Kimilili, Kenya
                [6 ]Nifty Fox Creative, Sheffield, UK
                [7 ]Healthcare Consultant, Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, The Gambia
                [8 ]Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine, The Gambia
                [9 ]School of Health and Related Research, University of Sheffield, Sheffield, UK
                [10 ]Medical Aid International, Bedford, UK
                [11 ]School of Population Health, University of Auckland, Auckland, New Zealand
                [12 ]Department of Medicine, Therapeutics and Dermatology, Kenyatta University, Nairobi, Kenya
                [13 ]International Union Against Tuberculosis and Lung Disease, Paris, France
                [14 ]Division of Pulmonary Medicine, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
                [15 ]Division of Pulmonary Medicine, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
                [16 ]Asociación Latinoamericana del Tórax, Forum of International Respiratory Societies, Guatemala
                [17 ]The Epidemiological Laboratory (Epi-Lab) for Public Health, Research and Development, Khartoum Sudan
                [18 ]University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK
                [19 ]UCL Respiratory, University College London, London, UK
                [20 ]AstraZeneca, Cambridge, UK
                [21 ]Department of Paediatrics and Child Health, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa
                [22 ]Centre for Respiratory Diseases Research, Kenya Medical Research Institute, Nairobi, Kenya
                [23 ]Department of Primary Care Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
                [24 ]International Primary Care Respiratory Group, Larbert, Scotland, UK
                [25 ]Makerere University Lung Institute, College of Health Sciences, Makerere University, Kampala, Uganda
                [26 ]GlaxoSmithKline, Brentford, UK
                [27 ]The Woolcock Institute of Medical Research, The University of Sydney, Sydney, NSW, Australia
                [28 ]Global Initiative for Asthma (GINA), Fontana, WI, USA
                [29 ]Noncommunicable Diseases Department, World Health Organization, Geneva, Switzerland
                [30 ]Global Allergy & Airways Patient Platform, Vienna, Austria
                [31 ]Department of Pulmonology, Celal Bayar University Medical Faculty, Manisa, Turkey
                [32 ]Global Alliance Against Chronic Respiratory Diseases, Geneva, Switzerland
                [33 ]University of New South Wales, Sydney, NSW, Australia
                [34 ]University of Cambridge, Cambridge, UK
                Author notes

                GBM and KM are Joint senior authors

                Correspondence to: Professor Kevin Mortimer, University of Cambridge, Cambridge, UK. email: kjm20@ 123456cam.ac.uk
                Article
                10.5588/ijtld.22.0270
                9621306
                36281039
                02633356-8d2c-4fb6-8122-e7cb3f2e6e20
                © 2022 The Union

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Licence ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.

                History
                : 9 May 2022
                : 30 May 2022
                Page count
                Pages: 11
                Funding
                KM reports advisory board fees from AstraZeneca (Cambridge, UK). JRH has received personal payment and payment to his employer for educational and advisory work from pharmaceutical companies that make medicines to treat COPD. AY reports advisory board fees from AstraZeneca, Novartis (Basel, Switzerland), Abdi İbrahim (Istanbul, Turkey), GlaxoSmithKline (GSK; Brentford, UK), Bilim (Istanbul, Turkey). DMGH has received personal payment for educational and advisory work from pharmaceutical companies that make medicines to treat COPD and is a member of the Board of Directors and Science Committee of the Global Initiative for Chronic Obstructive Lung Diseases (GOLD). MC has received personal payment for educational and advisory work from pharmaceutical companies that make medicines to treat Asthma and COPD. JC reports advisory board fees from AstraZeneca. EMK reports grants from the NIHR Global Health Research Unit on Respiratory Health (RESPIRE) and Seqirus UK (Maidenhead, UK); personal fees from AstraZeneca and GSK; and is board director of the International Primary Care Respiratory Group. TW reports advisory board/speaker fees from Amgen (Thousand Oaks, CA, USA), AstraZeneca, GSK, Novartis, Sanofi/Regeneron (Paris, France). HKR reports research grants from AstraZeneca, GlaxoSmithKline and Novartis; honoraria for advisory boards for AstraZeneca, Chiesi (Parma, Italy), GSK, Novartis and Sanofi-Genzyme (Cambridge, MA, USA); consulting from AstraZeneca and Novartis; and independent medical education presentations from AstraZeneca, Boehringer Ingelheim (Ingelheim, Germany), Chiesi, GlaxoSmithKline, Sanofi-Genzyme and Teva (Tel Aviv, Israel). RM has received grants and advisory board fees/speakers fees from AstraZeneca, GSK and Boehringer Ingelheim.
                Categories
                Original Articles

                asthma,copd,non-communicable disease,chronic respiratory disease,inhalers,essential medicines

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